Sr. Regulatory Affairs Specialist

Regulatory Affairs Long Beach, California


Description

Position at HydraFacial

ABOUT US:

BeautyHealth is a category-creating beauty health company focused on bringing innovative products to market. Our flagship brand, HydraFacial, is a non-invasive and approachable beauty health platform and ecosystem with a powerful community of estheticians, consumers and partners, bridging medical and consumer retail to democratize and personalize skin care solutions for the masses. Leading the charge in beauty health as a category-creator, HydraFacial uses a unique delivery system to cleanse, extract and hydrate with our patented hydradermabrasion technology and super serums that are made with nourishing ingredients, providing an immediate outcome and creating an instantly gratifying glow in just three steps and 30 minutes. HydraFacial® and Perk™ products are available in over 90 countries with over 20,000 Delivery Systems globally and millions of treatments performed each year.

HydraFacial is hiring a Sr. RA Specialist who will be responsible for being involved in  global regulatory submissions from start to finish.

HERE'S WHAT YOU'LL BE DOING: 

  • Working on cross functional teams and communicating complex regulatory requirements and technical data in an understandable way for any audience.
  • Managing multiple applications simultaneously and interfacing directly with regulatory bodies, agencies, distributors and other stakeholder to resolve application issues.
  • Authoring and compiling technical documentation for submissions, licensing and re-licensing, and change reporting.
  • Researching and reporting relevant regulations and conducting impact/gap analyses to ensure smooth implementations in assigned markets.
HERE'S WHAT YOU'LL BRING TO THE ROLE:
  • 5+ years direct experience in a RA role at a Medical Device manufacturer.
  • Cosmetics RA experience is a plus
  • Bachelor degree in science or business disciplines.
  • Excellent writing skills, in global technical file and submission documents.
  • Ability to work in a fast-paced environment managing multiple projects / countries.
  • Ability to work in 21 CFR 820 & ISO 13485 environment.

What else can you expect with HydraFacial?

PERKS! We proudly offer full health benefits, that’s medical, dental, vision, FSAs, HSAs, Accident Insurance, and even Pet Insurance for your furry family to name a few. We also provide Basic Life/AD&D and Long-Term Disability coverage at no cost to you! Top these benefits off with an Employee Stock Purchase Plan. A 401(K) plan with an Employer Match because your retirement is just as important to us. The best part about it, you will be fully vested immediately!

Every person here is a key player in our success. We are firm believers in making the little things count each day, so that the big things will follow. If this sounds like you, come check us out! This is the perfect opportunity to work with some of the best leaders in the industry while you gain the global and strategic experience to add to your professional toolbox.

We mean it when we say you’ll love this role!